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Perhaps you are currently working as a nurse at a University Hospital involved in clinical trials or at a GP office and you would like to work in the pharmaceutical industry? Or you are working in Pharmacovigilance (e.g. as Drug Safety Associate) and would like to change into the clinical trial area?
Here you have the possibility to change into a role as Clinical Data Manager in R&D at LEO Pharma. An interesting job, making a difference.
About the Job
In LEO Pharma, Patient, People and Performance matters. We have an exciting 2025 strategy and a strong pipeline - well balanced with many projects in early-stage as well as in late-stage development.
As Clinical Data Manager you will be responsible for accurate, timely and consistent clinical data. You will provide clinical data management support to cross-functional trial teams.
You will have the opportunity to work with world-wide:
Phase I trials: First-in-man trials
Phase II trials: Dose-finding trials
Phase III trials: Confirmation safety and efficacy trials
Phase IV trials / Non-interventional Studies: Safety trials in real life setting
You will assume a large variety of tasks and responsibilities within the Data Management area, both with hands-on work and CRO oversight. You will develop (and have oversight of) the data management processes from trial set up to closure of the clinical data bases. You will learn to write Data Management Plans on how to ensure correct data for analysis, CRF specifications on how to collect the data, database lock documentation. You will work closely together with Data Management CROs and EDC vendors. You will become a part of the team of Data Managers in the Biometrics Department and you will be working with your DM colleagues in an organisation where knowledge sharing and team work is key. In DM we are willing to go the extra mile, while at the same time keeping a good a sound work-life balance.
You will be responsible for the DM area as a member in the clinical trial team and will be working closely with the statistical programmer, statistician, safety advisor, medical experts and the trial manager within the frames of Global Clinical Operations.
Your Qualifications
You are an educated Nurse, BSc or MSc in Pharmacy, Medical Secretary, Medical Laboratory Technologist, Laboratory Technician, Pharmaconomist or Biomedical Engineer (BSc or MSc).
You have proven training in databases and IT systems (either at hospital, private practise or pharma company). You have minimum 3 years of job related experience.
You must be eager and fast to learn, self-driven, with strong collaboration and communication skills. You must be a positive team player with a good sense of humor.
You are fully proficient in both written and spoken English. You must be able handle MS Word, Excel, Power Point with ease. GCP training will be an advantage. Programming skills will also be an advantage.
We offer
- An exciting environment, with a high degree of influence on own job
- You will be part of an engaged DM team and as member of this team you will be part of setting the direction for the future
- Skilled colleagues in the trial teams, in a learning and international organisation
- Support in getting up to speed as Clinical Data Manager
The position refers to Head of Data Management, Lisbet Groes.
Application deadline
Please submit your application no later than January 31 2018 via the link below - we look forward to receiving it.
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